Comparing Chemoradiotherapy and Immunotherapy Before Surgery for Locally Advanced Cervical Cancer
Tests nab-paclitaxel, cisplatin and sintilimab before surgery in people with locally advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 70 with locally advanced cervical cancer, stage IB3 or IIA2, who have not yet had treatment for it.
- Age
- 18 to 70 years
- Sex
- Women only
- Disease stage
- Cervical cancer of squamous cell, adenocarcinoma or adenosquamous type, FIGO 2018 stage IB3 or IIA2, with at least one measurable tumor. HPV-related cancer.
- Earlier treatment
- Cannot have had any other anti-tumor treatment for cervical cancer before.
- Biomarker or test result
- Cancer must be HPV-related. Blood counts, kidney and liver tests must be within set limits. Hepatitis B, hepatitis C and HIV tests must be negative.
Main reasons for not taking part
- Another clinical trial within 30 days before the first chemotherapy dose
- Cervical cancer that is not HPV-related
- Another cancer in the past 5 years (except one the investigator judges to be gone)
- Active infection needing treatment through the body, or positive HIV, hepatitis B or hepatitis C test
- Nerve damage in the hands or feet of grade 2 or higher
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07088731, who can take part
Where in China
- Department of Gynecological OncologyBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Trial code
- NCT07088731
- Record updated
- 22 September 2025
- Original description
For locally advanced cervical cancer, there are two main treatment options:Read full original descriptionShow less
A Prospective, Single-Center, Randomized Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin and Sintilimab in Neoadjuvant Treatment of Locally Advanced Cervical Cancer
For locally advanced cervical cancer, there are two main treatment options:
One is radical chemoradiotherapy (a combination of radiotherapy and chemotherapy aimed at curing the disease).
The other is having neoadjuvant treatment first (treatment given before the main surgery to shrink the tumor) followed by radical surgery.
So far, there's no clear answer on which of these two options is better. In general, cervical cancer responds well to immunotherapy. But we still don't know for sure if adding immunotherapy to neoadjuvant chemotherapy can improve the treatment effect for locally advanced cervical cancer, or even make it better than radical chemoradiotherapy.
This study aims to compare the effects of two approaches: radical chemoradiotherapy versus neoadjuvant chemotherapy plus immunotherapy followed by surgery.
Inclusion: Aged ≥ 18 years and ≤ 70 years; Cervical cancer with pathological types being squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; Staged IB3 or IIA2 according to the FIGO 2018 staging system, as assessed by the investigator; ECOG performance status of 0-2, or KPS score ≥ 70; Expected survival time of more than 3 months; Having at least one measurable lesion in accordance with RECIST 1.1; Laboratory test results meeting the following criteria without drug intervention:; Hemoglobin ≥ 90 g/dl, neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L; Creatinine ≤ 1.5 times the upper limit of normal range; Total bilirubin, alanine transaminase (ALT), and aspartate transaminase (AST) < 2 times the upper limit of normal; Postmenopausal, or reproductive-aged women who meet all the following conditions: non-lactating, not pregnant, and able to use effective contraceptive measures during the study treatment period; Voluntarily participating in this study and signing the informed consent form.
Exclusion: Participated in other clinical trials within 30 days before receiving the first dose of chemotherapy drugs or during the treatment period; Previously received any other anti-tumor treatment for cervical cancer; Concurrent diseases or abnormal test results that interfere with the subject's ability to receive anti-tumor treatment as judged by the investigator, such as the estimated inability of the subject to tolerate at least 2 cycles of neoadjuvant chemotherapy plus surgery or concurrent chemoradiotherapy, etc; Participation in this study is deemed not conducive to the maximum benefit of the subject as judged by the investigator; Non-HPV-related cervical cancer; Patients with known allergies to the active ingredients of the study drugs or their excipients; Diagnosed with other malignant tumors in the past 5 years (except those judged to be cured by the investigator); Active infections requiring systemic treatment; Positive for human immunodeficiency virus (HIV) antibody; Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody; Needing to receive other anti-tumor treatments during the study treatment period; Peripheral neuropathy with a grade of ≥ 2 according to the NCI-CTCAE (Version 5.0).